Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia

Part of paid clinical trials in Denver, Colorado.

Sponsor
Milton S. Hershey Medical Center
Study ID
NCT06281756
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Blood Pressure
  • Blood Pressure, High
  • Insomnia
  • Insomnia Chronic
  • Insomnia, Primary

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cognitive Behavioral Treatment for Insomnia (CBT-I) — BEHAVIORAL
    Subjects will receive therapy for 8 weeks
  • Trazodone — DRUG
    Non-remitting subjects will receive Trazodone (dosage) for 8 weeks
  • Placebo — OTHER
    Non-remitting subjects will receive placebo for 8 weeks

Study Details

Individuals who have insomnia with short sleep duration (ISS) differ from individuals who have insomnia with normal sleep duration (INS) in terms of health risks (i.e., hypertension) and treatment response. This study will examine whether patients with ISS and INS demonstrate a differential response to two common insomnia treatments. One is behavioral, Cognitive Behavioral Therapy for Insomnia (CBT-I). The other is a widely prescribed, non-habit-forming medication, trazodone used at a low dose. The investigators' findings could lead to evidence-based treatment guidelines that help clinicians more effectively match treatments to insomnia patients and reduce associated health problems.

Key Dates

Start date
Mar 20, 2024
Status verified
Nov 2025
Primary completion
Nov 30, 2027
Completion
May 31, 2028

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with placebo
    Subjects with insomnia treated with Cognitive Behavior Treatment for Insomnia (CBT-I) for 8 weeks, then non-remitting subjects received placebo for 8 weeks.
  • Active Comparator: Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with Trazodone
    Subjects with insomnia treated with Cognitive Behavior Treatment for Insomnia (CBT-I) for 8 weeks, then non-remitting subjects received trazodone for 8 weeks.

Primary Outcome Measure

Remission of insomnia symptoms following Cognitive Behavioral Therapy for Insomnia (CBT-I) [ Time Frame: 9 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
National Jewish HealthDenverColorado80206-2761
Roxane Horberg
[email protected]
303-270-2850
Rachel Johnson
[email protected]
303 398-1058
Penn State UniversityHersheyPennsylvania17033
Carrie Criley
[email protected]
717-531-4123
University of PittsburghPittsburghPennsylvania15213-3203
Laurie Brar
[email protected]
412-723-7998

Find similar trials in Denver, CO

By condition
Insomnia
By specialty
Mental healthSleep medicine
By research site
National Jewish Health· Denver, COPenn State University· Hershey, PAUniversity of Pittsburgh· Pittsburgh, PA

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